College of Pharmacy and Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, Korea.
Korea Institute for Health and Social Affairs, Seoul, Korea.
J Dent Res. 2015 Sep;94(9 Suppl):212S-9S. doi: 10.1177/0022034515587862. Epub 2015 May 22.
The purpose of this study was to examine the association between bisphosphonate exposure and osteonecrosis of the jaw (ONJ) in Korean patients with osteoporosis. A nested case-control study was performed using the claims database during 2002 to 2010 provided by the National Health Insurance Service. We identified a cohort of individuals with diagnosis of osteoporosis during 2002 to 2010. Cases and controls were identified during 2004 to 2010, and the date of potential cases of ONJ was defined as the index date. Bisphosphonate exposure was evaluated during 2 y prior to the index date. The association between bisphosphonate exposure and ONJ was tested by performing a conditional logistic regression analysis for matched data, and odds ratios (ORs) with 95% confidence intervals (CIs) were presented. Subjects were classified as nonuser, recent user, past user, or continuous user, depending on the prescription of bisphosphonates in 2 periods (1 to 2 y and 0 to 1 y prior to the index date). Continuous users were defined as patients who were exposed to bisphosphonate in both periods. We also examined the impact of bisphosphonate medication compliance by measuring the cumulative duration of exposure (CDE) on the risk of ONJ. A total of 212 cases with ONJ and 2,120 controls matched by sex, age, income level, and insurance type were identified among 109,787 patients with osteoporosis out of 1,025,340 enrollees in the sample cohort. The odds of having ONJ after adjusting for patient comorbidities significantly increased in continuous users of bisphosphonates (OR, 3.9; 95% CI, 2.4 to 6.2) compared to nonusers. Increased odds of ONJ were observed as CDE increased. The adjusted OR in patients with 1.5 y < CDE ≤ 2 y prior to the index date was 7.8 (95% CI, 4.0 to 15.5) versus nonusers. Our study results support significantly increased occurrences of potential ONJ in patients with osteoporosis who were exposed to bisphosphonates compared to those without exposure.
本研究旨在探讨双膦酸盐暴露与韩国骨质疏松症患者下颌骨坏死（ONJ）之间的关联。使用国家健康保险服务提供的 2002 年至 2010 年的理赔数据库进行了一项巢式病例对照研究。我们确定了一组在 2002 年至 2010 年期间被诊断为骨质疏松症的患者。病例和对照于 2004 年至 2010 年期间确定，ONJ 潜在病例的日期被定义为索引日期。在索引日期前 2 年内评估双膦酸盐暴露情况。通过对匹配数据进行条件逻辑回归分析来检验双膦酸盐暴露与 ONJ 之间的关联，并呈现比值比（OR）及其 95%置信区间（CI）。根据双膦酸盐在 2 个时期（索引日期前 1 至 2 年和 0 至 1 年）的处方情况，将受试者分为非使用者、近期使用者、过去使用者或连续使用者。连续使用者被定义为在两个时期均暴露于双膦酸盐的患者。我们还通过测量暴露的累积持续时间（CDE）来检查双膦酸盐药物依从性对 ONJ 风险的影响。在样本队列中，1025340 名参保人中，有 212 名 ONJ 病例和 2120 名性别、年龄、收入水平和保险类型匹配的对照病例在 109787 名骨质疏松症患者中被确定。在调整了患者合并症后，与非使用者相比，连续使用双膦酸盐的患者发生 ONJ 的几率显著增加（OR，3.9；95%CI，2.4 至 6.2）。随着 CDE 的增加，ONJ 的发病几率也增加。在索引日期前 1.5 年<CDE≤2 年的患者中，调整后的 OR 为 7.8（95%CI，4.0 至 15.5），而非使用者的 OR 为 1。我们的研究结果支持与未暴露于双膦酸盐的患者相比，暴露于双膦酸盐的骨质疏松症患者发生潜在 ONJ 的几率显著增加。
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